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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
07 Jan 2008 - 22 Jan 2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Ashes (residues), coal
EC Number:
931-322-8
Molecular formula:
Not applicable (UVCB substance)
IUPAC Name:
Ashes (residues), coal

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Breeding farm BioTest s.r.o., Konárovice, 281 25, CZ, RČH CZ 21760152
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 158-170 g (see table No. 1)
- Fasting period before study: About 20 hours prior to oral administration the animals were not fed, water was given ad libitum
- Housing: 3 animals of one sex in one plastic breeding cage Velaz T4
- Diet (e.g. ad libitum): ST 1 BERGMAN, standard pelleted diet ad libitum (producer: Mill Kocanda, Jesenice u Prahy)
- Water (e.g. ad libitum): Drinking tap water ad libitum (quality corresponding to Regulation No. 252/2004 Czech Coll. of Law)
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%):30-70
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 07 Jan 2008 To: 22 Jan 2008

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% methylcellulose in water
Details on oral exposure:
VEHICLE
- 0.5% methyl cellulose in water
- Justification for choice of vehicle: It is not toxic. Is it possible to prepare a homogeneous suspension of the test substance in this vehicle.
- Lot/batch no.: DT157078

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

DOSAGE PREPARATION:
Immediately before administration, the test substance was weighed, mixed in vehicle (0.5% methyl cellulose in water) and the resulting suspension was administered by gavage. The single volume of administered suspension was 1mL/100 g body weight.

CLASS METHOD
- Rationale for the selection of the starting dose: according to the methology
Testing schedule (according to EU Method B.1 tris Annex 1D):
Step No. 1: 3 females dosed 2000 mg/kg. Result: no deaths. Therefore, Step No. 2: 3 females dosed 2000 mg/kg. Result: no deaths. Thus, no further testing necessary.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females (Step No.1: 3 females, Step No.2: 3 females)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: After administration, the animals were observed individually. Twice on the first day (30 minutes and 3 hours after application), twice on the second day (in the morning and in the afternoon), and daily thereafter up to the end of the study. Observations included changes in skin and fur, eyes, visible mucous membranes, behaviour, somatomotor activity, reactions to stimuli, presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system.
Animals were weighed before administration, on day 8 of the study and on day 15 prior to sacrifice. Body weight gain was calculated from body weight at the start and at the end of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: All test animals survived. Animals were sacrificed on day 15 by injection of a veterinary preparation T61 (1 mL iv.) and gross necropsy was carried out. Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities occurred
Clinical signs:
No clinical sings of intoxication were observed.
Body weight:
No effects on body weight (gain) observed.
Gross pathology:
No macroscopic changes were observed.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
The test substance administered orally at 2000 mg/kg bw caused no death of animals. No clinical signs of intoxication were observed. No pathologic macroscopic changes were diagnosed.
The test substance does not fufil the requirements to be classified according to DSD and CLP criteria.